PROLENE EPH8710HRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705031233485), received between Jun 7, 2018 and Sep 14, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Separation” (19 reports).

21 other recalls cover devices cleared under the same FDA submission (K133356); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. The problem of pulling off suture needle happened when suturing Ventricular septal defect. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752194 ↗
• MalfunctionOct 9, 2025Break; Break

  IT WAS REPORTED THAT DURING A VASCULAR SURGERY PROCEDURE, SEVERAL SUTURES TORE UNUSUALLY QUICKLY WHILE KNOTTING. OUT OF FIVE SUTURES USED, THREE BROKE. NEW SUTURES HAD TO BE OPENED. THERE IS STILL ONE SUTURE LEFT FROM THE AFFECTED BOX, WHICH I CAN INCLUDE WITH THE COMPLAINT SUBMISSION. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 15, ACTION TAKEN WHEN EVENT OCCURRED? NEW SUTURES OPENED, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23254973 ↗
• MalfunctionOct 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT DURING A VASCULAR SURGERY PROCEDURE, SEVERAL SUTURES TORE UNUSUALLY QUICKLY WHILE KNOTTING. OUT OF FIVE SUTURES USED, THREE BROKE. NEW SUTURES HAD TO BE OPENED. THERE IS STILL ONE SUTURE LEFT FROM THE AFFECTED BOX, WHICH I CAN INCLUDE WITH THE COMPLAINT SUBMISSION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23254972 ↗
• MalfunctionOct 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT DURING A VASCULAR SURGERY PROCEDURE, SEVERAL SUTURES TORE UNUSUALLY QUICKLY WHILE KNOTTING. OUT OF FIVE SUTURES USED, THREE BROKE. NEW SUTURES HAD TO BE OPENED. THERE IS STILL ONE SUTURE LEFT FROM THE AFFECTED BOX, WHICH I CAN INCLUDE WITH THE COMPLAINT SUBMISSION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23254971 ↗
• MalfunctionAug 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19993528 ↗
• MalfunctionAug 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19993458 ↗
• MalfunctionAug 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992937 ↗
• MalfunctionAug 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992714 ↗
• MalfunctionApr 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THE SUTURE DETACHES FROM THE NEEDLES REPEATEDLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675409 ↗
• MalfunctionApr 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THE SUTURE DETACHES FROM THE NEEDLES REPEATEDLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675408 ↗
• MalfunctionApr 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THE SUTURE DETACHES FROM THE NEEDLES REPEATEDLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675404 ↗
• MalfunctionApr 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THE SUTURE DETACHES FROM THE NEEDLES REPEATEDLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675374 ↗
• MalfunctionApr 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THE SUTURE DETACHES FROM THE NEEDLES REPEATEDLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675373 ↗
• MalfunctionApr 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THE SUTURE DETACHES FROM THE NEEDLES REPEATEDLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675367 ↗
• MalfunctionMar 14, 2023Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THE SUTURE DETACHES FROM THE NEEDLES REPEATEDLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538513 ↗
• MalfunctionMar 14, 2023Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON(B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THE SUTURE DETACHES FROM THE NEEDLES REPEATEDLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538507 ↗
• MalfunctionMar 14, 2023Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THE SUTURE DETACHES FROM THE NEEDLES REPEATEDLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538503 ↗
• MalfunctionMar 14, 2023Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON 3/2/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THE SUTURE DETACHES FROM THE NEEDLES REPEATEDLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538484 ↗
• MalfunctionSep 28, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DAVID OPERATION ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE GOT SPLIT IN THE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496067 ↗
• InjuryJun 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING KNOTTING IN THE SURGERY. ONLY THE SUTURE COULD BE SEEN, BUT THE NEEDLE COULD NOT BE SEEN. THE INSTRUMENT NURSE IMMEDIATELY INFORMED THE SURGEON AND ITINERANT NURSE TO SUSPEND THE SURGERY . THEY LOOKED UP TOGETHER ON AND OFF THE STAGE, BUT STILL COULDN'T FIND IT. THEY CONTACTED THE RADIOLOGY DEPARTMENT TO TAKE A FILM. IT WAS FOUND IN THE PERICARDIUM, BUT THE SPECIFIC LOCATION COULD NOT BE DETERMINED. THEY RE COORDINATED THE CP MACHINE, AND TOOK FOUR HOURS TO TAKE OUT THE NEEDLE WITH THE HELP OF THE CP MACHINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14621761 ↗
• MalfunctionJun 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN THE SUTURE WAS DRAWN CLOSE TO SEW FOR THE SEVENTH TO THE EIGHTH STITCHES DURING THE PROCEDURE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10111664 ↗
• MalfunctionApr 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. THE NEEDLE FELL INSIDE OF PATIENT, AND FINALLY IT WAS RETRIEVED THROUGH CT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. SURGERY WAS DELAYED FOR ABOUT 30 TO 40 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT IS STABLE NOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 9995160 ↗
• MalfunctionApr 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. THE NEEDLE FELL INSIDE OF PATIENT, AND FINALLY IT WAS RETRIEVED THROUGH CT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. SURGERY WAS DELAYED FOR ABOUT 30 TO 40 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT IS STABLE NOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 9995159 ↗
• InjuryJun 7, 2018Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC DISSECTION PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON POURED WATER ON THE SUTURE AND THE SUTURE DID NOT SLIDE WELL WHICH TORE THE LARGE ARTERY. THE SURGEON OPINED THAT THERE WAS NO ISSUE WITH THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Injury; No Code Available

  MAUDE report 7579547 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133356. One submission often covers many models, so check the product and lot details in each record.

• Z-1515-2025 · Mar 7, 2025 · Open, Classified
  PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
• Z-1096-2025 · Dec 20, 2024 · Open, Classified
  PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ca
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

…and 6 more.